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ART Restorations With High-viscosity Glass-ionomer Cement Versus Hall Technique in Primary Molars

ART Restorations With High-viscosity Glass-ionomer Cement Versus Hall Technique in Primary Molars

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05462808
Enrollment
40
Registered
2022-07-18
Start date
2019-03-20
Completion date
2021-04-01
Last updated
2022-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Teeth Retained

Brief summary

Primary molars are the teeth with the highest caries tendency among primary teeth due to their anatomical features such as wide and flat interface areas. However, some difficulties are encountered during the removal of caries due to the structural features of primary molars and the young age of the child. Therefore, in the treatment of primary molars, Atraumatic Restorative Treatment (ART), in which the soft parts of the carious lesion are cleaned with the help of a sharp hand tool and restored with an adhesive glass ionomer cement (GIC) that releases fluoride, in the following years, the deciduous teeth were removed with a minimally invasive approach. Hall technique, in which a stainless steel crown (SSC) is placed without preparation for treatment, has come to the fore.

Detailed description

Many restorative materials, especially GIC, have been used for ART procedures, and with the advancing technology, high-viscosity glass ionomer cements with improved mechanical and chemical properties have emerged. In recent years, zinc-added HVGICs and nano-filled resin-modified HVGICs have been introduced. The Hall Technique has been suggested in the treatment of asymptomatic decayed primary molars in anxious and fearful patients to ensure patient cooperation. In this technique, it is aimed to stop the progression of caries by covering the carious deciduous molars with SSC and cutting their relationship with the oral environment, without the need for local anesthesia and tooth preparation. Thus, as the bacteria cannot use the carbohydrates in the oral environment, the number of bacteria in the environment will also decrease.

Interventions

DRUGHigh viscosity glass ionomer cement

High viscosity glass ionomer cement

Stainless steel crown

Sponsors

Esra Oz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
5 Years to 7 Years
Healthy volunteers
Yes

Inclusion criteria

* children with no systemic disease, * children who had a Frankl Behavioral Scale score 2, * children who have no occlusal problems or bad habits, * children presenting between 2-5 caries lesion in primary molars.

Exclusion criteria

* teeth with presence of radyolusens in furcation and/or periradicular areas, * teeth with pathologic resorption and internal/external resorption

Design outcomes

Primary

MeasureTime frameDescription
Hall techniqueup to 18 monthsThe restorations were scored as Alpha (A), clinically ideal restoration ''successful''; Bravo (B), clinically ''acceptable''; Charlie (C), clinically unacceptable restoration ''unsuccessful''. Outcomes criteria for assessment of the Hall Technique were made according to Innes et al.

Secondary

MeasureTime frameDescription
Atraumatic restorative treatmentup to 18 monthsClinical evaluations of teeth treated with ART using EQUIA Forte were performed according to the modified USPHS criteria established by a modification of the United States Public Health Service (USPHS) clinical evaluation criteria.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026